Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00103168 |
|
Recruitment Status :
Completed
First Posted : February 8, 2005
Last Update Posted : July 9, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastrointestinal Stromal Tumor | Drug: imatinib mesylate | Phase 3 |
OBJECTIVES:
Primary
- Assess whether there is a difference in overall survival between intermediate and high-risk localized GIST patients undergoing complete surgery alone and those undergoing complete surgery plus adjuvant imatinib mesylate 400 mg daily for two years Secondary
- Assess whether there is a difference in relapse-free survival and relapse-free interval between GIST undergoing complete surgery alone and those undergoing surgery + adjuvant Imatinib mesylate 400 mg daily for two years.
- Determine the safety of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, risk category (high vs intermediate), tumor site (gastric vs other), and resection level (R0 vs R1).
- Arm I: Patients receive adjuvant oral imatinib mesylate once daily for 2 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients are observed (without receiving further antitumoral therapy) every 3 months for 2 years.
After completion of study treatment, patients in arm I are followed every 3 months for 2 years. All patients are then followed every 4 months for 3 years and at least annually thereafter.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 3.5 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 908 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatinib Mesylate (Glivec) Versus No Further Therapy After Complete Surgery |
| Actual Study Start Date : | December 2004 |
| Actual Primary Completion Date : | October 2008 |
| Actual Study Completion Date : | September 2017 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Imatinib mesylate
400 mg/day for 2 years
|
Drug: imatinib mesylate
400 mg/day for 2 years |
| No Intervention: Control |
- Overall survival
- Relapse-free survival
- Relapse-free interval
- Adverse events
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed gastrointestinal stromal tumor
- Localized disease
-
Meets 1 of the following criteria:
-
At high-risk of relapse, defined by 1 of the following criteria:
- Tumor size > 10 cm
- Mitotic rate > 10/50 high-power field (HPF)
- Tumor size > 5 cm AND mitotic rate > 5/50 HPF
-
At intermediate-risk of relapse, defined by 1 of the following criteria:
- Tumor size < 5 cm AND mitotic rate 6-10/50 HPF
- Tumor size 5-10 cm AND mitotic rate < 5/50 HPF
-
- Tumor must stain positive for Kit (CD117) by polyclonal DAKO antibody staining
-
Must have undergone complete resection of the primary tumor at least 2 weeks, but no more than 3 months, before study entry
-
Meets criteria for 1 of the following resection levels:
- R0 (clear margins)
-
R1, defined by 1 of the following criteria:
- Margins of resection are contaminated by tumor, but no macroscopic tumor is left behind
- Intraoperative tumor rupture
- Shelling-out procedure
- Endoscopic maneuver
-
No residual macroscopic disease after surgery
- Regional positive lymph nodes allowed provided they have been macroscopically excised
-
-
No distant metastases*, including any of the following:
- Peritoneal lesion not contiguous to the primary tumor
- Liver metastases
- Hemoperitoneal metastases NOTE: *Even if a complete resection (R0) was performed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL (transfusions allowed)
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN
- No uncontrolled liver disease
- No chronic viral hepatitis at risk of reactivation
Renal
- Creatinine < 1.5 times ULN
- No uncontrolled chronic renal disease
Cardiovascular
- No New York Heart Association class III-IV cardiac disease
- No congestive heart failure
- No myocardial infarction within the past 2 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 3 months after study participation
- No uncontrolled diabetes
- No uncontrolled active infection
- No HIV infection
- No psychological, familial, sociological, or geographical condition that would preclude study compliance or participation
- No other severe and/or uncontrolled medical disease
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other prior molecular targeted or biologic therapy
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts
- No concurrent anticancer biologic agents
Chemotherapy
- No prior chemotherapy for gastrointestinal stromal tumors
- No concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
- No concurrent anticancer radiotherapy
Surgery
- See Disease Characteristics
- Prior non-curative surgery allowed (e.g., surgery with main diagnostic intent or emergency surgery with symptomatic intent)
Other
- No prior imatinib mesylate
- No prior randomization to this study
-
No concurrent therapeutic anticoagulation with coumarin derivatives
- Concurrent therapeutic low-molecular weight heparin or mini-dose coumarin derivatives (equivalent to oral warfarin 1 mg/day) allowed for prophylaxis of central venous catheter thrombosis
- No other concurrent antitumoral therapy
- No other concurrent anticancer agents
- No other concurrent investigational drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103168
Show 50 study locations
| Study Chair: | Paolo G. Casali, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | |
| Study Chair: | Axel Le Cesne, MD | Gustave Roussy, Cancer Campus, Grand Paris | |
| Study Chair: | Andres Poveda, MD | Instituto Valenciano De Oncologia |
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00103168 |
| Other Study ID Numbers: |
EORTC-62024 EORTC-62024 ISG-62024 FRE-FNCLCC-EORTC-62024 GEIS-EORTC-62024 2004-001810-16 ( EudraCT Number ) |
| First Posted: | February 8, 2005 Key Record Dates |
| Last Update Posted: | July 9, 2018 |
| Last Verified: | July 2018 |
|
gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Neoplasms Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |